Medicines regulators urged to approve drug to treat head and neck cancer

Patient’s insurer refuses to cover €40,000 cost of treatment as drug has not been approved for particular cancer

 Maria Waters: she  has been advised by three consultants that Pembro is the best course of treatment for her cancer. Photograph: Nick Bradshaw

Maria Waters: she has been advised by three consultants that Pembro is the best course of treatment for her cancer. Photograph: Nick Bradshaw

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The husband of a cancer patient has written to Irish medicines regulators urging them to act quickly on approving a drug that will treat her head and neck cancer.

Robert Waters wrote to officials at the National Centre for Pharmacoeconomics (NCPE) after Monica Waters’ health insurer refused to cover the near €40,000 cost of a treatment with pembrolizumab because the drug has not been approved.

Mr Waters called on the NCPE to assist the couple “on an urgent basis”. His wife is coping with her third bout of the disease.

“Your approval is the missing piece of a potentially lifesaving solution for my wife,” he wrote in an email seeking details of how long the approval process for the drug might take.

Noting that Ms Waters’ health insurer Irish Life “would be happy to pay for this treatment if it was approved for first line treatment of head and neck cancers”, he asked whether there was any scope for approval on an “exceptional case by case basis”.

Ms Waters has been advised by three consultants that Pembro is the best course of treatment for her cancer. In the absence of NCPE and HSE approval, the Waters family has had to find close to €10,000 to fund the first round of her treatment last week. She will require another three rounds of treatment with the drug.

Pembrolizumab, better known as Pembro or Keytruda, was first approved for use by Irish patients in 2016. It has been approved in the State for the treatment of three different forms of cancer – melanoma, lung cancer and Hodgkin lymphoma – but not the head and neck cancer Ms Waters has.

Minister for Health Simon Harris also cleared the drug for use by 221 patients affected by the Cervical Check scandal outside the normal NCPE structure. He later extended that availability to all cervical cancer patients in late 2018.

Waiting list

It is understood the drug is also among those on a waiting list for approval and/ or HSE funding to treat a number of other types of cancer. For some of these at least it has been waiting over two years for approval and funding. Industry sources suggest that it is likely to be well into 2021 before any approval to use the drug to treat head and neck cancer is forthcoming.

The NCPE first looked at Pembro as a treatment for head and neck cancers in November last year. That initial review, which was completed early last month, suggested a full health technology assessment, which is usual with such medicines to assess clinical and cost effectiveness.. This will take around 90 days once a formal submission is made by the drug’s manufacturer MSD.

There are currently more than 700 patients a year diagnosed with mouth, head and neck cancer in Ireland.

Health insurer VHI broke ranks with its peers last year by announcing that it would provide wider access to certain cancer drugs, including Pembro, for certain cancers. Irish Life Health and Laya Healthcare said at the time that they would continue to await NCPE guidance.

Ironically, MSD is currently investing millions of euro to build a plant in Swords to manufacture Keytruda in Ireland. Keytruda is approved in different countries for 11 different cancers, and is currently seeking approval for a range of other indications. By 2025, industry analysts expect it to be the top selling drug worldwide.